A Cost–Consequence Analysis of Preemptive SLCO1B1 Testing for Statin Myopathy Risk Compared to Usual Care

There is a well-validated association between SLCO1B1 (rs4149056) and statin-associated muscle symptoms (SAMS). Preemptive SLCO1B1 pharmacogenetic (PGx) testing may diminish the incidence of SAMS by identifying individuals with increased genetic risk before stat...

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Autores principales:	Charles A. Brunette, Olivia M. Dong, Jason L. Vassy, Morgan E. Danowski, Nicholas Alexander, Ashley A. Antwi, Kurt D. Christensen
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	<i>SLCO1B1</i> statin-associated muscle symptoms pharmacogenetics cost–consequence analysis cardiovascular disease precision medicine Medicine R
Acceso en línea:	https://doaj.org/article/bce280f5a3324b0bba6cd0a0da6a1f6f
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spelling	oai:doaj.org-article:bce280f5a3324b0bba6cd0a0da6a1f6f2021-11-25T18:07:22ZA Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care10.3390/jpm111111232075-4426https://doaj.org/article/bce280f5a3324b0bba6cd0a0da6a1f6f2021-10-01T00:00:00Zhttps://www.mdpi.com/2075-4426/11/11/1123https://doaj.org/toc/2075-4426There is a well-validated association between <i>SLCO1B1</i> (rs4149056) and statin-associated muscle symptoms (SAMS). Preemptive <i>SLCO1B1</i> pharmacogenetic (PGx) testing may diminish the incidence of SAMS by identifying individuals with increased genetic risk before statin initiation. Despite its potential clinical application, the cost implications of <i>SLCO1B1</i> testing are largely unknown. We conducted a cost–consequence analysis of preemptive <i>SLCO1B1</i> testing (PGx+) versus usual care (PGx−) among Veteran patients enrolled in the Integrating Pharmacogenetics in Clinical Care (I-PICC) Study. The assessment was conducted using a health system perspective and 12-month time horizon. Incremental costs of <i>SLCO1B1</i> testing and downstream medical care were estimated using data from the U.S. Department of Veterans Affairs’ Managerial Cost Accounting System. A decision analytic model was also developed to model 1-month cost and SAMS-related outcomes in a hypothetical cohort of 10,000 Veteran patients, where all patients were initiated on simvastatin. Over 12 months, 13.5% of PGx+ (26/193) and 11.2% of PGx− (24/215) participants in the I-PICC Study were prescribed Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline-concordant statins (Δ2.9%, 95% CI −4.0% to 10.0%). Differences in mean per-patient costs for lipid therapy prescriptions, including statins, for PGx+ compared to PGx− participants were not statistically significant (Δ USD 9.53, 95% CI −0.86 to 22.80 USD). Differences in per-patient costs attributable to the intervention, including PGx testing, lipid-lowering prescriptions, SAMS, laboratory and imaging expenses, and primary care and cardiology services, were also non-significant (Δ− USD 1004, 95% CI −2684 to 1009 USD). In the hypothetical cohort, <i>SLCO1B1</i>-informed statin therapy averted 109 myalgias and 3 myopathies at 1-month follow up. Fewer statin discontinuations (78 vs. 109) were also observed, but the <i>SLCO1B1</i> testing strategy was 96 USD more costly per patient compared to no testing (124 vs. 28 USD). The implementation of <i>SLCO1B1</i> testing resulted in small, non-significant increases in the proportion of patients receiving CPIC-concordant statin prescriptions within a real-world primary care context, diminished the incidence of SAMS, and reduced statin discontinuations in a hypothetical cohort of 10,000 patients. Despite these effects, <i>SLCO1B1</i> testing administered as a standalone test did not result in lower per-patient health care costs at 1 month or over 1 year of treatment. The inclusion of <i>SLCO1B1</i>, among other well-validated pharmacogenes, into preemptive panel-based testing strategies may provide a better balance of clinical benefit and cost.Charles A. BrunetteOlivia M. DongJason L. VassyMorgan E. DanowskiNicholas AlexanderAshley A. AntwiKurt D. ChristensenMDPI AGarticle<i>SLCO1B1</i>statin-associated muscle symptomspharmacogeneticscost–consequence analysiscardiovascular diseaseprecision medicineMedicineRENJournal of Personalized Medicine, Vol 11, Iss 1123, p 1123 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	<i>SLCO1B1</i> statin-associated muscle symptoms pharmacogenetics cost–consequence analysis cardiovascular disease precision medicine Medicine R
spellingShingle	<i>SLCO1B1</i> statin-associated muscle symptoms pharmacogenetics cost–consequence analysis cardiovascular disease precision medicine Medicine R Charles A. Brunette Olivia M. Dong Jason L. Vassy Morgan E. Danowski Nicholas Alexander Ashley A. Antwi Kurt D. Christensen A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care
description	There is a well-validated association between <i>SLCO1B1</i> (rs4149056) and statin-associated muscle symptoms (SAMS). Preemptive <i>SLCO1B1</i> pharmacogenetic (PGx) testing may diminish the incidence of SAMS by identifying individuals with increased genetic risk before statin initiation. Despite its potential clinical application, the cost implications of <i>SLCO1B1</i> testing are largely unknown. We conducted a cost–consequence analysis of preemptive <i>SLCO1B1</i> testing (PGx+) versus usual care (PGx−) among Veteran patients enrolled in the Integrating Pharmacogenetics in Clinical Care (I-PICC) Study. The assessment was conducted using a health system perspective and 12-month time horizon. Incremental costs of <i>SLCO1B1</i> testing and downstream medical care were estimated using data from the U.S. Department of Veterans Affairs’ Managerial Cost Accounting System. A decision analytic model was also developed to model 1-month cost and SAMS-related outcomes in a hypothetical cohort of 10,000 Veteran patients, where all patients were initiated on simvastatin. Over 12 months, 13.5% of PGx+ (26/193) and 11.2% of PGx− (24/215) participants in the I-PICC Study were prescribed Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline-concordant statins (Δ2.9%, 95% CI −4.0% to 10.0%). Differences in mean per-patient costs for lipid therapy prescriptions, including statins, for PGx+ compared to PGx− participants were not statistically significant (Δ USD 9.53, 95% CI −0.86 to 22.80 USD). Differences in per-patient costs attributable to the intervention, including PGx testing, lipid-lowering prescriptions, SAMS, laboratory and imaging expenses, and primary care and cardiology services, were also non-significant (Δ− USD 1004, 95% CI −2684 to 1009 USD). In the hypothetical cohort, <i>SLCO1B1</i>-informed statin therapy averted 109 myalgias and 3 myopathies at 1-month follow up. Fewer statin discontinuations (78 vs. 109) were also observed, but the <i>SLCO1B1</i> testing strategy was 96 USD more costly per patient compared to no testing (124 vs. 28 USD). The implementation of <i>SLCO1B1</i> testing resulted in small, non-significant increases in the proportion of patients receiving CPIC-concordant statin prescriptions within a real-world primary care context, diminished the incidence of SAMS, and reduced statin discontinuations in a hypothetical cohort of 10,000 patients. Despite these effects, <i>SLCO1B1</i> testing administered as a standalone test did not result in lower per-patient health care costs at 1 month or over 1 year of treatment. The inclusion of <i>SLCO1B1</i>, among other well-validated pharmacogenes, into preemptive panel-based testing strategies may provide a better balance of clinical benefit and cost.
format	article
author	Charles A. Brunette Olivia M. Dong Jason L. Vassy Morgan E. Danowski Nicholas Alexander Ashley A. Antwi Kurt D. Christensen
author_facet	Charles A. Brunette Olivia M. Dong Jason L. Vassy Morgan E. Danowski Nicholas Alexander Ashley A. Antwi Kurt D. Christensen
author_sort	Charles A. Brunette
title	A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care
title_short	A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care
title_full	A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care
title_fullStr	A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care
title_full_unstemmed	A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care
title_sort	cost–consequence analysis of preemptive <i>slco1b1</i> testing for statin myopathy risk compared to usual care
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/bce280f5a3324b0bba6cd0a0da6a1f6f
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A Cost–Consequence Analysis of Preemptive <i>SLCO1B1</i> Testing for Statin Myopathy Risk Compared to Usual Care

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